Structured Sensory-Based Occupational Therapy in Children With Autism
Effects of Structured Sensory-Based Occupational Therapy on Occupational Performance and Sensory-Motor Outcomes in Children With Autism Spectrum Disorder: A Controlled Clinical Study
1 other identifier
interventional
40
1 country
1
Brief Summary
This controlled clinical study will investigate the effects of a 12-week structured sensory-based occupational therapy intervention on occupational performance, sensory processing, gross motor development, and eating behaviors in children with autism spectrum disorder. Forty children aged 3-9 years will be assigned to either an intervention group receiving face-to-face occupational therapy twice weekly or a control group receiving an individualized home program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2026
CompletedFirst Posted
Study publicly available on registry
August 27, 2026
CompletedStudy Start
First participant enrolled
August 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
August 28, 2026
August 1, 2026
2 months
August 24, 2026
August 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Occupational Performance
Occupational performance will be assessed using the performance score of the Canadian Occupational Performance Measure. Higher scores will indicate better perceived occupational performance.
Baseline and Week 12
Change in Satisfaction with Occupational Performance
Satisfaction with occupational performance will be assessed using the satisfaction score of the Canadian Occupational Performance Measure. Higher scores will indicate greater satisfaction.
Baseline and Week 12
Secondary Outcomes (3)
Change in Sensory Processing
Baseline and Week 12
Change in Gross Motor Development
Baseline and Week 12
Change in Eating Behaviors
Baseline and Week 12
Study Arms (2)
Structured Sensory-Based Occupational Therapy Group
EXPERIMENTALParticipants in this group will receive 40-minute, face-to-face structured sensory-based occupational therapy sessions twice weekly for 12 weeks. The intervention will be individualized according to each child's sensory and functional needs and will include tactile, proprioceptive, vestibular, visual-motor, gross motor, feeding-related, and occupational performance activities. Session content will be progressively adapted according to the child's development. Caregivers will also receive brief recommendations for home practice.
Home Program Control Group
ACTIVE COMPARATORParticipants in this group will receive individualized home-based activity recommendations using materials available in the home environment. The home program will be implemented for 12 weeks and will be monitored weekly for approximately 10 minutes using verbal information and visual records provided by caregivers. Participants will not receive face-to-face structured sensory-based occupational therapy during the study period.
Interventions
The intervention will consist of individualized sensory-based occupational therapy activities addressing tactile, proprioceptive, vestibular, visual-motor, gross motor, feeding-related, and occupational performance needs. It will be delivered face-to-face for 40 minutes, twice weekly, over 12 weeks, and will be progressively adapted according to each child's clinical needs and development.
Caregivers will implement individualized home-based sensory and functional activity recommendations using materials available in the home environment. The program will continue for 12 weeks and adherence will be monitored weekly through caregiver reports and visual records.
Eligibility Criteria
You may qualify if:
- Children aged 3-9 years
- Diagnosis of autism spectrum disorder according to DSM-5 criteria
- Level 2 autism spectrum disorder
- Residence in Istanbul
- Written informed consent provided by a parent or legal guardian
You may not qualify if:
- Presence of an additional neurological, psychiatric, genetic, or developmental diagnosis
- Regular medication use that may affect study outcomes
- History of epilepsy or seizures
- Inability to participate in the assessment or intervention procedures
- Participation in another structured sensory-based occupational therapy program during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emre DANSUKlead
Study Sites (1)
Emre Dansuk
Istanbul, Beykoz, 34815, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emre DANSUK, PhD
Medipol University
Central Study Contacts
Burak Menek, PhD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Because of the nature of the interventions, participants and treating physiotherapists will be aware of the allocated intervention. Outcome assessments will be conducted by an independent physiotherapist who will be blinded to group allocation. Statistical analyses will be performed by a biostatistician who will be blinded to the coded group assignments.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 24, 2026
First Posted
August 27, 2026
Study Start
August 28, 2026
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
August 28, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Beginning immediately after publication and available for five years.
- Access Criteria
- Data will be made available to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the corresponding author and will require institutional approval and a signed data-sharing agreement. Data will be provided solely for the purposes specified in the approved proposal.
De-identified individual participant data underlying the results reported in the published article will be made available upon reasonable request to the corresponding author for scientifically sound research purposes. Data access will be subject to approval of the proposed use and completion of an appropriate data-sharing agreement, in accordance with institutional policies and applicable ethical requirements.